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| + | [[Category:RCRIM]] | ||
== Links == | == Links == | ||
| − | [[Study Design, Study Participation and Subject Data|CDISC HL7 Project Page]] | [[Stage | + | [[Study Design, Study Participation and Subject Data|CDISC HL7 Project Page]] | [[Stage IB Project Page|Stage I-B Page]] |
== Useful Guides == | == Useful Guides == | ||
| Line 14: | Line 15: | ||
== Study Design == | == Study Design == | ||
*[[Media:ConsolidatedSD.zip|Study Design Ballot Reconciliation]] | *[[Media:ConsolidatedSD.zip|Study Design Ballot Reconciliation]] | ||
| + | |||
| + | *[[Media:StudyDesignTest.zip|Study Design Test Files]] | ||
== Subject Data == | == Subject Data == | ||
No document at this time | No document at this time | ||
| + | |||
| + | == SDTM Mapping for Study Participation, Study Design and Subject Data == | ||
| + | * [[Media:SDTM Mapping July 25, 2011.xlsx|SDTM Mapping July 25, 2011]] | ||
== Test Plan == | == Test Plan == | ||
*[[Media:Test_Plan_Study_Design_and_Study_Participation.doc|Study Design and Study Participation Test Plan]] | *[[Media:Test_Plan_Study_Design_and_Study_Participation.doc|Study Design and Study Participation Test Plan]] | ||
| − | == | + | == Ballot Package September 2009 == |
| − | + | The ballot package can be found at : http://www.hl7.org/v3ballot/html/welcome/environment/index.htm | |
| − | |||
| − | + | On the tree on the left click on the following location on the tree: | |
| − | + | HL7 Version 3 Standards / Universal Domains / Regulated Studies / | |
| + | You will find a sub folder for each of the ballot packages names Study Design Topic, Study Participation Topic and Subject Data Topic. | ||
| + | The Subject Data standard is new. | ||
| + | The following are the high level changes to the study participation standard: | ||
| + | *Some arrows act relationships arrows point a different direction | ||
| + | *Some act relationship class codes have changed | ||
| + | *There is now a separate concept from the study site (organization) from the place activities happen (physical location) | ||
| + | *We consider body parts as part of the subject as opposes to access points of the subject | ||
| − | * | + | The following are the high level changes to the study design standard: |
| − | * | + | *Some arrows act relationships arrows point a different direction |
| − | * | + | *Some act relationship class codes have changed |
| − | + | *One time point can belong to many arms at the same time. | |
| + | *Added location where activities can occur | ||
| + | *Added the place activities happen (physical location) | ||
| + | *We consider body parts as part of the subject as opposes to access points of the subject | ||
| + | *You can define certain characteristics the experimental unit has to be assigned to a time point | ||
| + | == DSTU Testing == | ||
| + | [[Functional Requirement Resources]] | ||
| − | + | [[Study Design Function - Test Case Matrix]] | |
| − | [[ | + | [[Study Data XForms]] |
| − | [[Media: | + | [[Media:javascript.zip]] |
| − | [[Media: | + | XForms with narrative XForms: [[Media:Xforms_v3.zip]] (need to add .img folder from previous version of XFroms.) |
| − | [[ | + | [[HL7 Study Participation and Patient Narrative/CDA DSTU Draft Testing Plan]] |
| − | |||
| − | [[ | + | [[HL7 Study Participation xForm and associated documents (Zip file)]] |
| − | |||
| − | [[ | + | [[HL7 Patient Narrative associated documents (Zip file)]] |
| − | [[ | + | [[HL7 Study Design Installation Guide (zip file)]] |
| − | + | == Meeting Minutes and Agendas == | |
| − | [[ | + | [[2013 Stage II Meeting Agendas and Minutes]] |
| − | [[ | + | [[2012 Stage II Meeting Agendas and Minutes]] |
| − | [[ | + | [[2011 Stage II Meeting Minutes]] |
| − | [[ | + | [[2010 Stage II Meeting Minutes]] |
| − | [[ | + | [[2009 Stage II Meeting Minutes]] |
| − | [[ | + | [[2008 Stage II Meeting Minutes]] |
| − | [[ | + | [[2007 Stage II Meeting Minutes]] |
Latest revision as of 18:59, 18 April 2013
Contents
Links
CDISC HL7 Project Page | Stage I-B Page
Useful Guides
For those wanting assistance in editing wiki pages have a look at these pages (Add any useful links you find)
- Basic Editing - Page on this Wiki, with additional links to other resources
- http://meta.wikimedia.org/wiki/Help:Editing
- http://en.wikipedia.org/wiki/Wikipedia:Cheatsheet
Study Participation
Study Design
Subject Data
No document at this time
SDTM Mapping for Study Participation, Study Design and Subject Data
Test Plan
Ballot Package September 2009
The ballot package can be found at : http://www.hl7.org/v3ballot/html/welcome/environment/index.htm
On the tree on the left click on the following location on the tree:
HL7 Version 3 Standards / Universal Domains / Regulated Studies /
You will find a sub folder for each of the ballot packages names Study Design Topic, Study Participation Topic and Subject Data Topic.
The Subject Data standard is new.
The following are the high level changes to the study participation standard:
- Some arrows act relationships arrows point a different direction
- Some act relationship class codes have changed
- There is now a separate concept from the study site (organization) from the place activities happen (physical location)
- We consider body parts as part of the subject as opposes to access points of the subject
The following are the high level changes to the study design standard:
- Some arrows act relationships arrows point a different direction
- Some act relationship class codes have changed
- One time point can belong to many arms at the same time.
- Added location where activities can occur
- Added the place activities happen (physical location)
- We consider body parts as part of the subject as opposes to access points of the subject
- You can define certain characteristics the experimental unit has to be assigned to a time point
DSTU Testing
Functional Requirement Resources
Study Design Function - Test Case Matrix
XForms with narrative XForms: Media:Xforms_v3.zip (need to add .img folder from previous version of XFroms.)
HL7 Study Participation and Patient Narrative/CDA DSTU Draft Testing Plan
HL7 Study Participation xForm and associated documents (Zip file)
HL7 Patient Narrative associated documents (Zip file)
HL7 Study Design Installation Guide (zip file)
Meeting Minutes and Agendas
2013 Stage II Meeting Agendas and Minutes
